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Elevidys

FDA Adds Boxed Liver Warning and Limits Elevidys to Ambulatory Boys 4 and Up

The decision also requires intensive monitoring with a 200‑patient study to clarify liver risk after postmarket deaths.

FDA Lifts Hold on Elevidys Shipments to Ambulatory Duchenne Patients

Sarepta Temporarily Halts Elevidys Shipments Under FDA Request